Stimulator For The Control of a Bodily Function

Abstract

The present invention provides a device for the stimulation of smooth muscle tissue. The device includes a stimulator arranged to provide a signal to the smooth muscle tissue to control response of the smooth muscle tissue, and an interface arranged to allow programming of a controller of the stimulator. The interface may interact with an external controller. The device finds use in controlling smooth muscle tissue, such as a neosphincter, for the control of urinary or faecal incontinence in a patient.

1 . A device for the stimulation of smooth muscle tissue, comprising a stimulator arranged to provide a signal to the smooth muscle tissue to control response of the smooth muscle tissue, and an interface arranged to allow programming of a controller of the stimulator. 
   
   
       2 . A device in accordance with  claim 1 , wherein the signal is passed from the stimulator to the smooth muscle tissue via a stimulation lead. 
   
   
       3 . A device in accordance with  claim 2 , wherein the stimulation lead has at least one electrode to deliver electrical stimulation to the smooth muscle tissue. 
   
   
       4 . A device in accordance with any one of the preceding claims, wherein the smooth muscle tissue is one of a sphincter and a neosphincter. 
   
   
       5 . A device in accordance with any one of the preceding claims wherein the signal delivered to the smooth muscle tissue is a symmetric or an asymmetric wave form. 
   
   
       6 . A device in accordance with  claim 5 , wherein the wave form is a biphasic wave form. 
   
   
       7 . A device in accordance with  claim 6 , wherein the stimulator is arranged to apply a delay between two phases of the biphasic wave form. 
   
   
       8 . A device in accordance with  claim 7 , wherein the delay between the two phases is in the range from approximately 0 to 100 milliseconds. 
   
   
       9 . A device in accordance with any one of the preceding claims, wherein the signal is an electric signal with a current amperage in the range of zero to twenty-five milliamps in each phase. 
   
   
       10 . A device in accordance with  claim 1 ,  claim 2  or  claim 3  wherein the impedance of the stimulation lead is in the range of approximately 300 ohms to 2000 ohms. 
   
   
       11 . A device in accordance with any one of the preceding claims, wherein the device is implantable within a patient. 
   
   
       12 . A device in accordance with any one of the preceding claims, further comprising at least one sensor. 
   
   
       13 . A device in accordance with  claim 12 , wherein the sensor is arranged to monitor the response of the smooth muscle tissue. 
   
   
       14 . A device in accordance with  claim 12 , wherein the at least one sensor is arranged to monitor the response of a bodily function of the patient. 
   
   
       15 . A device in accordance with  claim 14 , wherein the bodily function is the fullness of the bladder of the patient. 
   
   
       16 . A device in accordance with  claim 14 , wherein the bodily function is the fullness of the rectum of the patient. 
   
   
       17 . A device in accordance with any one of  claims 12  to  16 , further comprising storage means arranged to store data collected from the at least one sensor. 
   
   
       18 . A device in accordance with any one of the preceding claims, further including a power source in the form of an in-built battery. 
   
   
       19 . A device in accordance with  claim 17 , wherein the battery is rechargeable. 
   
   
       20 . A device in accordance with any one of  claims 1  to  12 , further including a power source in the form of a charge storing device. 
   
   
       21 . A device in accordance with  claim 20 , wherein the charge storing device is a capacitor. 
   
   
       22 . A device in accordance with any one of the preceding claims, further including a switch arranged to control stimulation of the device. 
   
   
       23 . A device in accordance with  claim 22 , wherein the switch is a magnetic switch. 
   
   
       24 . A device in accordance with  claim 22 , wherein the switch is a wireless communication device capable of sending an electromagnetic signal to the device. 
   
   
       25 . A device in accordance with any one of the preceding claims, further comprising means to provide feedback on the status of the device. 
   
   
       26 . A device in accordance with  claim 25 , wherein the feedback is provided by a tactile signal, such as a vibration. 
   
   
       27 . A device in accordance with  claim 25 , wherein the feedback is provided by an audible signal. 
   
   
       28 . A device in accordance with  claim 25 , wherein the feedback is provided by a visual signal. 
   
   
       29 . A device in accordance with any one of  claims 25  to  28 , wherein the feedback includes information on the power status of the device. 
   
   
       30 . A device in accordance with any one of  claims 25  to  29 , wherein the feedback includes information on the power level of the device. 
   
   
       31 . A device for the stimulation of smooth muscle tissue, comprising a stimulator arranged to provide a signal to the smooth muscle tissue to control response of the smooth muscle tissue, and means to provide feedback to a patient on the status of a controller for the stimulator. 
   
   
       32 . A device in accordance with  claim 31 , wherein the feedback is provided via a tactile signal, such as a vibration. 
   
   
       33 . A device in accordance with  claim 31  or  32 , wherein the feedback is provided by an audible signal. 
   
   
       34 . A device in accordance with any one of  claims 31  to  33 , wherein the feedback is provided by a visual signal. 
   
   
       35 . A device in accordance with any one of  claims 31  to  34 , wherein the feedback includes information on the power status of the device. 
   
   
       36 . A device in accordance with any one of  claims 31  to  35 , wherein the feedback includes information on the power level of the device. 
   
   
       37 . A device in accordance with any one of  claims 31  to  36 , wherein the feedback includes information on the fullness of the bladder or rectum. 
   
   
       38 . A device for use with a stimulator arranged to provide a signal to smooth muscle tissue to control response of the smooth muscle tissue, the device comprising at least one sensor arranged to monitor a bodily function of a patient. 
   
   
       39 . A device in accordance with  claim 38 , wherein the bodily function is the fullness of the bladder of the patient. 
   
   
       40 . A device in accordance with  claim 38 , wherein the bodily function is the fullness of the rectum of the patient. 
   
   
       41 . A device in accordance with  claim 38 , wherein the bodily function is the commencement and/or cessation of urination by the patient. 
   
   
       42 . A device in accordance with  claim 38 , wherein the bodily function is the commencement and/or cessation of defecation by the patient. 
   
   
       43 . A sensor arranged to provide feedback of a bodily function associated with one of a sphincter and a neosphincter. 
   
   
       44 . A system for the stimulation of smooth muscle tissue, comprising a device in accordance with any one of  claims 1  to  43  and an external controller arranged to communicate with the device. 
   
   
       45 . A system in accordance with  claim 44 , wherein the external controller is arranged to program the stimulator controller. 
   
   
       46 . A system in accordance with  claim 44  or  claim 45 , wherein the external controller is arranged to upload data to a storage means. 
   
   
       47 . A system in accordance with  claim 44 ,  claim 45  or  claim 46 , wherein the external controller is arranged to download data from a storage means. 
   
   
       48 . A device for the stimulation of smooth muscle tissue, comprising a stimulator arranged to provide a signal arranged to stimulate the smooth muscle tissue, and a controller arranged to control the signal provided by the stimulator in a manner which influences the innervation of the smooth muscle tissue. 
   
   
       49 . A method for calibrating a device for the stimulation of smooth muscle tissue, comprising the steps of measuring the impedance of a stimulation lead arranged to provide a stimulus signal to the smooth muscle tissue, measuring the response of the smooth muscle tissue, and, if necessary, adjusting the signal. 
   
   
       50 . A method of stimulating a smooth muscle tissue, comprising the steps of utilising a device in accordance with  claim 1  to control the smooth muscle tissue, by applying a signal to the smooth muscle tissue to cause the smooth muscle tissue to contract. 
   
   
       51 . A method for stimulating the pelvic floor, comprising the steps of utilising a device in accordance with  claim 1  to stimulate the pelvic floor to cause the pelvic floor muscle to contract, thereby strengthening the pelvic floor. 
   
   
       52 . A device in accordance with any one of  claims 1  to  43 , comprising a plurality of stimulators to stimulate a plurality of discrete smooth muscle neosphincters. 
   
   
       53 . A device in accordance with  claim 51 , wherein the plurality of bodily functions includes at least one of the control of urine flow from the bladder and the control of stools and/or flatus from the rectum.